Healthy Skepticism Library item: 13432

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Heavey S.
U.S. lawmakers seek J&J, Amgen anemia drug records
Reuters 2008 Apr 1
http://www.reuters.com/article/marketsNews/idUKN0130607820080401?rpc=44

Full text:

WASHINGTON, April 1 (Reuters) – Two U.S. Democratic lawmakers have asked Johnson & Johnson (JNJ.N: Quote, Profile, Research) and Amgen Inc (AMGN.O: Quote, Profile, Research) for records on their advertising of controversial anemia drugs, saying aggressive marketing may have fueled potentially dangerous use.

Amgen’s top-selling product Aranesp and J&J’s Procrit have come under fire in recent months after researchers found patients given high doses died sooner or saw their cancers grow.

House of Representatives Energy and Commerce Committee Chairman John Dingell and Rep. Bart Stupak, in letters dated March 31, demanded records on the companies’ advertising campaigns and future promotional plans, as well as how much the drugmakers had spent on promotions since 2001.

“Millions of dollars have been poured into aggressive marketing campaigns, despite mounting evidence that these therapies pose serious risks,” Dingell said in a statement released on Tuesday.

“These potentially harmful drugs are over-prescribed and widely used off-label, and it’s time we evaluate the marketing practices used to push them,” said Dingell.

The injectable medicines are approved for treating chemotherapy-induced anemia, a condition in which low red blood cell levels can cause fatigue and weakness.

The erythropoiesis-stimulating agents, or ESAs, also are cleared for treating patients with kidney disease.

Last month, a U.S. Food and Drug Administration advisory panel urged limits on their use in cancer patients.

The committee of outside experts recommended against giving the medicines to patients with potentially curable cancers, or to those with advanced breast cancer or head and neck cancer. The FDA is considering that advice.

Dingell and Stupak, both from Michigan, told Johnson & Johnson they understood the company had ceased television and general circulation print advertisements for Procrit.

“Nevertheless, this Committee is concerned that J&J may have used misleading direct-to-consumer (DTC) television and print advertisements for Procrit to help fuel excessive and dangerous off-label use of the drug, particularly in connection with unsubstantiated ‘quality of life’ claims,” they wrote.

Johnson & Johnson spokesman Mark Wolfe said the drugmaker had received the lawmaker’s request and would cooperate.

The lawmakers said Amgen had not solicited patients directly but had targeted doctors, and marketed Aranesp to physicians in conjunction with Neupogen and Neulasta.

“We are concerned that such ‘bundling’ practices have helped fuel excessive and dangerous off-label use of Aranesp,” wrote Dingell and Stupak in their letter to Amgen Chief Executive Kevin Sharer.

Amgen said it would work to provide the requested records for Aranesp as well as its two other drugs for chemotherapy side effects, Neupogen and Neulasta.

Amgen said it offered rebates and discounts to customers but that such practices did not trigger off-label use. The company also said it had stopped advertising its ESA drugs to doctors. (Additional reporting by Lisa Richwine; Editing by Tim Dobbyn)